Analysis of Professional Competencies for the Clinical Research Data Management Profession

Abstract

OBJECTIVE: This job analysis was conducted to compare, assess and refine the competencies of the clinical research data management profession. MATERIALS AND METHODS: Two questionnaires were administered in 2015 and 2018 to collect information from data managers on professional competencies, types of data managed, types of studies supported, and necessary foundational knowledge. RESULTS: In 2018 survey, 67 professional competencies were identified. Job tasks differed between early- to mid-career and mid- to late-career practitioners. A large variation in the types of studies conducted and variation in the data managed by the participants was observed. DISCUSSION: Clinical research data managers managed different types of data with variety of research settings, which indicated a need for training in methods and concepts that could be applied across therapeutic areas and types of data. CONCLUSION: The competency survey reported here serves as the foundation for the upcoming revision of the Certified Clinical Data Manager (CCDMTM) exam.